Canadian clinical trial registry

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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

71 results found

Title
Status

 

M13-833 - A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

Closed to enrollment

M13-833 - A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

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DiagnosisALL AML all solid tumoursStudy StatusClosed to enrollment
PhaseI
AgeChild, Adult - (Up to 25 years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationOral tablet or suspension (Venetoclax) IV Chemotherapies
Last Posted Update2023-01-10
ClinicalTrials.gov #NCT03236857
International Sponsor
AbbVie
Principal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Daniel Morgenstern
CHU Ste-Justine- Dr. Henrique Bittencourt
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

NAIT Program 

nait.info@sickkids.ca

 

Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

Venetoclax is a medication, taken by mouth, which selectively binds and blocks a molecule called BCL-2, restoring the ability for natural cell death in cancer cells that have the BCL-2 marker. It is expected to slow or stop the growth of cancer cells.

The aim of this study is to evaluate the dose, safety, tolerability, antitumor activity and other characteristics of venetoclax given with or without chemotherapy.

Inclusion Criteria
  • Participants must have cancer that has come back or is not responding to current therapy
  • Age up to 25 years
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

KEYNOTE-051 (MK-3475) - A Phase I/II Study of Pembrolizumab (MK-3475) in Children With Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)

Closed to enrollment

KEYNOTE-051 (MK-3475) - A Phase I/II Study of Pembrolizumab (MK-3475) in Children With Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)

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DiagnosisMelanoma, Lymphoma, Solid Tumor, Hodgkin Lymphoma, Microsatellite-instability-high Solid Tumor, Non-Hodgkin Lymphoma, Other solid tumoursStudy StatusClosed to enrollment
PhaseI/II
AgeChild - (6 Months to 17 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment Administrationintravenous
Last Posted Update2023-01-05
ClinicalTrials.gov #NCT02332668
International Sponsor
Merck Sharp & Dohme Corp.
Principal Investigators for Canadian Sites
Montreal Children’s Hospital - Dr. Catherine Vézina
The Hospital for Sick Children - Dr. Vijay Ramaswamy
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

NAIT Program 

nait.info@sickkids.ca

 

 

 

Study Description

This is a study of pembrolizumab (antibody against a marker called PD1) in children and adolescents who have any of the following types of cancer:

  • advanced melanoma (now only open for patients age 12-18)
  • advanced, relapsed or refractory cancer (except brain tumours and leukemia) that have this PD1 marker (now closed) 
  • relapsed or refractory classical Hodgkin lymphoma 
  • advanced relapsed or refractory cancer (except brain tumours and leukemia) that is known to be "microsatellite-instability-high (MSI-H)"
  • advanced relapsed or refractory cancer (except brain tumours and leukemia) that is known to be "tumor-mutational burden-high" (TMB-H)"

Pembrolizumab is a human monoclonal antibody that binds and blocks PD-1 on tumors cells.  The PD-1 pathway is an immune system checkpoint that may be used by cancer tumour cells to help them trick the immune system (escape surveillance) and avoid being destroyed. By blocking the PD-1 pathway, pembrolizumab reactivates cells from the patient immune system to help it identify and destroy the cancer cells. It is expected to slow or stop the growth of cancer cells.

This study has two parts. Part 1 will find the recommended dose for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy of pembrolizumab therapy.

Inclusion Criteria
  • Age between 6 months and <18 years  (or between 3 years and <18 years of age for participants with Hodgkin's lymphoma) 
  • Locally-advanced, or metastatic cancer (except brain tumours and leukemia) that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriate. The cancer type has to meet one of the following types described in the "study description" section.
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
Publications

Geoerger B, Kang HJ, Yalon-Oren M, Marshall LV, Vezina C, Pappo A, Laetsch TW, Petrilli AS, Ebinger M, Toporski J, Glade-Bender J, Nicholls W, Fox E, DuBois SG, Macy ME, Cohn SL, Pathiraja K, Diede SJ, Ebbinghaus S, Pinto N. Pembrolizumab in paediatric patients with advanced melanoma or a PD-L1-positive, advanced, relapsed, or refractory solid tumour or lymphoma (KEYNOTE-051): interim analysis of an open-label, single-arm, phase 1-2 trial. Lancet Oncol. 2020 Jan;21(1):121-133. doi: 10.1016/S1470-2045(19)30671-0. Epub 2019 Dec 4.

CA209-744 - Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical)

Closed to enrollment

CA209-744 - Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical)

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DiagnosisHodgkin Disease, Hodgkin lymphoma, relapsed, refractoryStudy StatusClosed to enrollment
PhaseII
AgeChild, Adult - (5 Years to 30 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIV
Last Posted Update2023-01-05
ClinicalTrials.gov #NCT02927769
International Sponsor
Bristol-Myers Squibb
Principal Investigators for Canadian Sites
Montreal Children's Hospital – Dr. Sharon Abish
Alberta Children's Hospital – Dr. Victor Lewis
The Hospital for Sick Children - Dr. Ute Bartels
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

NAIT Program 

nait.info@sickkids.ca

 

 

 

Study Description

The purpose of this study is to determine whether the combination of two drugs called nivolumab and brentuximab vedotin is safe and effective in treating patients with Hodgkin's lymphoma that has come back or not responded to current therapy. 

Brentuximab vedotin is an antibody that specifically targets the CD30 marker of the Hodgkin Lymphoma cells and is able to kill them.

Nivolumab is a human monoclonal antibody that binds and blocks PD-1 on tumors cells.  The PD-1 pathway is an immune system checkpoint that may be used by cancer tumour cells to help them trick the immune system (escape surveillance) and avoid being destroyed. By blocking the PD-1 pathway, nivolumab reactivates cells from the patient's immune system to help it identify and destroy the cancer cells. It is expected to slow or stop the growth of cancer cells.

Inclusion Criteria

Child aged 5 to 18 with Hodgkin lymphoma who has already received treatment and either had no response (refractory) or experienced relapse.

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

 

PED-CITN-01 - 3CI Study: Childhood Cancer Combination Immunotherapy.

Completed

PED-CITN-01 - 3CI Study: Childhood Cancer Combination Immunotherapy.

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DiagnosisLymphoma, brain tumours except diffuse intrinsic pontine glioma, solid tumoursStudy StatusCompleted
PhaseI
AgeChild, Adult - (1 to 25 Years) RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment Administrationintravenous
Last Posted Update2023-01-05
ClinicalTrials.gov #NCT04500548
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Daniel Morgenstern


Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

NAIT Program 

nait.info@sickkids.ca

 

 

 

Study Description

Testing the Combination of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) in Children, Adolescent, and Young Adult Patients With Relapsed/Refractory Cancers That Have an Increased Number of Genetic Changes, The 3CI Study

This study investigates the side effects of the combination of two immunotherapy medications called nivolumab and ipilimumab, and to see how well they work in treating children, adolescents and young adults with cancers that have come back (relapsed) or does not respond to treatment (refractory) and have an increased number of genetic changes. Immunotherapy with nivolumab and ipilimumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

This study is being done to help doctors learn if the combination of nivolumab and ipilimumab can help children, adolescents, and young adults patients live longer.

This study will have two parts

  • PART I: A tissue sample from the tumour is analysed for "tumour mutation burden" level. Patients with elevated level may be eligible for Part II.
  • PART II: Patients receive receive treatment with nivolumab or nivolumab and ipilimumab.

 

Inclusion Criteria
  • Age from 12 months to 25 years
  • Patient with a cancer that has come back (relapsed) or does not respond to treatment (refractory)
  • All tumours can be considered except leukemia and diffuse intrinsic pontine glioma
  • The tumour will be tested (part 1). It needs to to have an increased number of genetic changes for the patient to be considered for part 2
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

NETTER-P - A Multicenter Open-label Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors, Pheochromocytoma and Paragangliomas (PPGL)

Open

NETTER-P - A Multicenter Open-label Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors, Pheochromocytoma and Paragangliomas (PPGL)

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DiagnosisGastroenteropancreatic Neuroendocrine Tumors, Pheochromocytoma, ParagangliomaStudy StatusOpen
PhaseII
Age12 to 17 Years OldRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Lutetium [177Lu] oxodotreotide/dotatate (Other Name: Lutathera) Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Last Posted Update2022-12-22
ClinicalTrials.gov #NCT04711135
International Sponsor
Advanced Accelerator Applications
Principal Investigators for Canadian Sites
CHU de Québec – Université Laval – Dr François-Alexandre Buteau
Centres
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

 

 

Study Description

This is a phase 2 study designed to evaluate the safety of a drug called Lutathera in patients 12 to <18 years old with GEP-NET and PPGL disease. For patients on the study, this drug will be infused 4 times at 8-week intervals. After the infusions are complete, a follow-up period will take place after the last dose for each patient who received at least one dose of Lutathera.

Inclusion Criteria
  • Patients must have a diagnosis of GEP-NET or PPGL that has gotten worse or can not be operated on
  • Patients must be between 12 to <18 years old at the time of enrollment
  • Patients must be up and about for over half of their waking hours
  • Patients and their families (as applicable) must agree to sign the written informed consent forms outlined by the study team

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

SJMB12 - A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

Closed to enrollment

SJMB12 - A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

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DiagnosisMedulloblastomaStudy StatusClosed to enrollment
PhaseII
AgeChild, Adult - (3 years to 39 years)RandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationVismodegib - Oral. Other drugs are given as usually administered for medulloblastoma therapy
Last Posted Update2022-10-04
ClinicalTrials.gov #NCT01878617
International Sponsor
St. Jude Children's Research Hospital
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Douglas Strother
The Hospital for Sick Children - Dr. Ute Bartels
CHU Ste-Justine- Dr. Sébastien Perreault
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

NAIT Program 

nait.info@sickkids.ca

 

Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

This study will assess the molecular subtype (abbreviated WNT, SHH, Non-WNT, Non-SHH) of patients with medulloblastoma. Based on the subtype And other factors, patients will be assigned to a "risk group", each risk group receiving specific treatment with chemotherapy and radiation therapy.

Patients with a specific molecular subtype called Sonic Hedgehog (SHH) will be treated with a medication taken by mouth, called vismodegib in addition to standard therapy, to directly target the molecular pathway. 

Inclusion Criteria
  • Patients between 3 and 22 years of age with medulloblastoma.
  • Patients between 22 and 40 years with medulloblastoma of the SHH subtype are eligible.
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

20110261 - A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Non Central Nervous System Tumors That Are Amenable to Direct Injection

Closed to enrollment

20110261 - A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Non Central Nervous System Tumors That Are Amenable to Direct Injection

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DiagnosisAdvanced Non-CNS Tumors, Other solid tumours Study StatusClosed to enrollment
PhaseI
AgeChild, Adult - (2 Years to 21 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationIntralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance
Last Posted Update2022-10-04
ClinicalTrials.gov #NCT02756845
International Sponsor
Amgen
Principal Investigators for Canadian Sites
CHU Ste Justine - Dr. Pierre Teira
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

Our immune system has the ability to recognize and destroy cancer cells. Under certain circumstances (eg. mutation) these cancer cells are no longer destroyed. Immunotherapy is a treatment which aims to "mobilize" the patient's immune defenses against his disease, by restoring the ability of the immune system to act against cancer cells.Talimogen laherparepvec is a product that stimulates the production of cells specialized in destroying cancer cells after being injected directly into the tumor.

The objective of this study is to evaluate the positive and negative effects induced by the injection of this new treatment. To do this, initially, children with any type of solid tumors will receive injections of dose recalculated from the dose already known for treatment of adults.Then depending on the results, the doses are gradually reduced. The effectiveness of this treatment and the analysis of its side effects will be evaluated by observing the disease's evolution, the side effects and the duration of its effects.

Inclusion Criteria
  • Children 2 to 20 years old with a recurrent solid tumor
  • Subject must be a candidate for intralesional injection, defined as one or more of the following:
    • at least 1 injectable lesion ≥ 10 mm in longest diameter
    • multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

ACT15378 ISAKIDS - Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

Open

ACT15378 ISAKIDS - Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

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DiagnosisAcute Lymphoblastic Leukemia, Acute Myeloid LeukemiaStudy StatusOpen
PhaseII
AgeChild - (up to 17 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIntravenous for isatuximab; Other drugs as usually administered for leukemia therapy
Last Posted Update2022-09-30
ClinicalTrials.gov #NCT03860844
International Sponsor
Sanofi
Principal Investigators for Canadian Sites
Montreal Children’s Hospital - Dr. Surabhi Rawal
BC Children's Hospital - Dr. Amanda Li
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

 

 

Study Description

This is study of a new medication called isatuximab (antibody against a marker called CD38) in combination with standard chemotherapy for children with acute lymphoblastic leukemia or acute myeloid leukemia that has relapsed or is refractory to treatment. The main objective of this study is to understand the anti-leukemia effect of this medication. 

Inclusion Criteria
  • Age between 28 days to less than 18 years of age
  • Acute lymphoblastic leukemia or acute myeloid leukemia that has relapsed or is refractory to treatment
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team